Ambu Inc. recalls

7 recalls in our records from 2016 to 2025: 7 FDA medical devices.

Recalls with full detail pages

• FDA · Medical devicesClass IAug 20, 2025

  Ambu Inc. medical device recall: Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator

  Potential for the manometer port being blocked rendering the manometer non-functional.

Earlier and other recalls

These link to the official agency notice.

• FDA · Medical devicesClass IIMay 14, 2025

  Ambu Inc. medical device recall: Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number:… Official notice ↗

  Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2…

• FDA · Medical devicesClass IINov 6, 2024

  Ambu Inc. medical device recall: Ambu¿ VivaSight 2 DLT Endobronchial tube Official notice ↗

  Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications…

• FDA · Medical devicesClass IIJan 17, 2024

  Ambu Inc. medical device recall: Ambu aView 2 A Monitor Official notice ↗

  Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm when mounting Ambu aView 2 Advance on a VESA…

• FDA · Medical devicesClass IIOct 4, 2023

  Ambu Inc. medical device recall: Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to… Official notice ↗

  Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in…

• FDA · Medical devicesClass IIJul 27, 2022

  Ambu Inc. medical device recall: Ambu VivaSight 2 DLT Official notice ↗

  Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway…

• FDA · Medical devicesClass IIMar 30, 2016

  Ambu Inc. medical device recall: Ambu Official notice ↗

  Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovered the problem during final quality control at manufacturing site. Damage…

Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.